1 Baobab Dried Fruit Pulp – An application for Novel Foods Approval in the EU as a food ingredient. 2 Application written and submitted on behalf of PhytoTrade Africa by the natural products consulting company: Herbal Sciences International Ltd, The Seed Bed Centre, Langston Road, Loughton Essex, IG10 3TQ, UK. Contact person: Dr John Wilkinson PhD Email: [email protected] Tel: +44 (0)794 169 6409 www.herbalsciencesinternational.com Applicant, producers and manufacturers of Baobab fruit pulp Full name and address of applicant: PhytoTrade Africa Post Net Suite #210 A Private Bag X4 Hout Bay 7872 Cape Town South Africa PhytoTrade Africa is registered in South Africa (registration number – 2006/001433/08). The registered name is SANPROTA (ASSOCIATION INCORPORATED UNDER SECTION 21) trading as PhytoTrade Africa. SANPROTA stands for the Southern African Natural Products Trade Association. Contact details: Mr. Cyril Lombard PhytoTrade Africa – London Office (registered place of business in the UK) Unit W215, Holywell Centre 1 Phipp Street, London EC2A 4PS, UK Tel: + 44 (0) 20 7739 8822, Fax: + 44 (0) 20 7739 7648 Mobile: + 44 (0) 7813 791497 E-mail: [email protected] Website: www.phytotradeafrica.com Producers and Manufacturers: PhytoTrade Africa has 58 members. Producers that want to export their Baobab fruit pulp are required to be assessed for the capacity to produce the product to appropriate standards. For this purpose PhytoTrade Africa operates a Pre-Qualified Supplier (PQS) system. The system includes assessment of members’ capabilities regarding: (1) Raw material supplies – volumes and quality (2) Traceability (3) Collation practices (4) Processing equipment (5) Packaging (6) Shipping (7) Handling orders and logistics (8) Conformity to PhytoTrade Africa’s Fair Trade and Environmental Charters (9) Exclusivity arrangements with selected partners and clients 3 Members who achieve PQS status are required to sell their relevant product to PhytoTrade Africa-approved manufacturers and commercial partners (9) above. The members either in, or intending to enter, the PQS programme for Baobab fruit pulp are listed in appendix 1. PQS-status members will only be entitled to access the EU market with Baobab fruit pulp meeting the specification as determined in this application. Further, PhytoTrade Africa collaborates with a trader and manufacturer of Baobab fruit pulp products in South Africa. This company is also listed in appendix 1. The company has HACCP standards and provides additional quality control capability as required by selected EU clients. This company will only be entitled to trade Baobab fruit pulp originating from PhytoTrade Africa’s members as listed in appendix 1. PhytoTrade Africa hereby registers the organisations and companies in Appendix 1 as our “consortium” of producers and manufacturers of Baobab fruit pulp. 4 CONTENTS 1.0 Introduction 2.0 Specification of Baobab dried fruit pulp 2.1 Phytochemistry of Baobab, Adansonia digitata 2.1.1 Seeds 2.1.2 Roots 2.1.3 Leaves 2.1.4 Bark 2.1.5 Fruit 2.2 Specification of PhytoTrade’s product – Baobab Dried Fruit Pulp 2.2.1 Introduction 2.2.2 Consistency of Baobab dried fruit pulp 3.0 Effect of the production process applied to Baobab dried fruit pulp 3.1 Stability of Baobab fruit pulp 4.0 History of the organism used as the source of Baobab dried fruit pulp 4.1 PhytoTrade Africa’s Pre-Qualified Supplier (PQS) system as quality control 5.0 Anticipated Intake of Baobab Fruit Pulp and extent of use 5.1 Introduction 5.2 Smoothie Drink Products 5.3 Cereal Bar Products 5.4 Anticipated levels with regard to the medicinal effects of Baobab 5.5 Conclusions 6.0 Information from previous human exposure to Baobab dried fruit pulp or its source 6.1 Traditional Food Uses of Baobab Fruit Pulp 6.2 Medicinal uses of Baobab Fruit Pulp 6.2.1 Folklore 6.3 Scientific studies 6.3.1 Trypanocidal properties 5 6.3.2 Anti-oxidant properties 6.3.3 Anti-inflammatory, analgesic, and anti-pyretic properties 6.3.4 Rehydration Treatment 6.3.5 Anti-viral properties 6.3.6 Hepatoprotection 6.4 Conclusion 7.0 Nutritional information on Baobab dried fruit pulp 7.1 Ascorbic Acid Content 7.2 Pectin Content 7.3 Fatty Acid Content 7.4 Nutritional constituents 7.5 Vitamin B Content 7.6 Trace Elements 7.7 Heavy Metal Analysis 7.8 Amino acid content 7.9 Microbiological Content 7.10 Pesticides Residues Content 7.11 Anti-nutrients in Baobab Dried Fruit Pulp 8.0 Safety Profile and Toxicity Studies of Baobab dried fruit pulp 8.1 Introduction - Literature surveys and history of use 8.2 Skin test- Irritation 8.3 LD50 Test in rodents 8.4 Cyclopropene Fatty Acids 8.5 LC50 brine shrimp assay 8.6 Adansonin 8.7 Ochratoxin Content 8.8 Cyanide Content 8.9 Toxicity of closely related species and the botanical family 8.10 Conclusion 9.0 Allergenicity of Baobab dried fruit pulp 10.0 Appendices 11.0 References 6 1.0 Introduction PhytoTrade Africa wish to place on the market in the European Union, dried Baobab Fruit Pulp derived from the fruits of Adansonia digitata for use as a nutritional food ingredient. Approval for this product is sought under the EC regulation No. 258/97 which is concerned with the introduction of novel foods and ingredients into the EU and ensures that the novel food in question is assessed for its safety prior to its introduction to the general public. The product is falling under and is also applicable under category 2 (categories of novel foods and novel food ingredients identified in Article 1 (2)(e) of Regulation (EC) No 258/97. This describes the novel food as “Foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating and breeding practices and which have a history of safe food use. Since the product is derived from plant material obtained from non - GM sources, the classification under category 4, “Scientific Classification of Novel Foods for the Assessment of Wholesomeness” which facilitates the nutritional and safety of the novel food, is applicable. According to Commission Recommendation 97/618/EC which provides guidance on presentation of data required for the safety assessment of novel foods, this product is classified as class 2 “Complex novel food from non –GM sources” and sub section 2.2 “the source of the novel foods which has no history of food use in the community (class 2.2)”. 2.0 Specification of Baobab Fruit Pulp The Baobab tree Adansonia digitata is a member of the Bombacaceae family which consists of around 20 genera and around 180 species (Heywood, 1993) including closely related species such as Adansonia gregori and Adanosnia madagascariensis (Shukla et al., 2001). Also known as the “upside down tree”, on pollination by fruit bats, it produces large green or brownish fruits which are capsules and characteristically indehiscent. The capsules contain a soft whitish powdery pulp and reinform, kidney shaped seeds (Sidibe & Williams 2002). The Baobab tree is found primarily in South Africa, Botswana, Namibia, Mozambique and Zimbabwe (Keith & Palgrave, 2000) but it is also common in America (Rashford, 1994), India, Sri Lanka, Malaysia, China, Jamaica and Holland (Sidibe & Williams, 2002). Its taxonomic classification is as follows: Kingdom Plantae Division Magnoliophyta Class Magnoliopsida Order Malvales Family Bombacaceae Bombacaceae in L. Watson and M.J. Dallwitz (1992 onwards) The families of flowering plants: descriptions. 2.1 Phytochemistry of Baobab, Adansonia digitata The literature has reported the isolation of a number of compounds from Adansonia digitata. These compounds have been found in a various parts of the plant including the seeds, roots, leaves, bark, and the fruits. 7 2.1.1 Seeds JP Bianchi et al (1982) reported the extraction of several class of chemicals from the unsaponfiable matter the seeds of two species Adansonia, A. grandieri and A. suarezensis. The major components were 4-demethylsterols (23-42%), tocopherols (10-37%), and hydrocarbons (15-17%). In both species, sitosterol (81-88%) was the most predominant 4-demethylsterol, and gamma-tocopherol (68-98%) was the major compound in the tocopherol group. In the hydrocarbon fraction, squalene (40-75%) was the major component. Gray et al (1986) reported the isolation of O-acetylethanolamine from the seeds of A. digitata. The dansyl derivative was isolated and used to identify the molecular structure. The O-acetylethanolamine is believed to have anti-inflammatory properties. Fatty acids have also been isolated from the seeds, including the identification of cyclopropenoid fatty acids (CPFA’s). These compounds are more fully discussed in section 8.4.) 2.1.2 Roots Kumar et al (1987) reported the isolation of a new flavonol from the roots of A. digitata. This flavonol glycoside was identified as fisetin-7-O-alpha- rhamnopyranoside. Y N Shukla et al (2001) reported in a review that 3,7-dihydroxy- flava-4-one-5-O-beta-D-galactopyranosyl-(1-4)-beta-D-glucopyranoside and also quercitin-7-O-beta-D-xylopyranoside had also been isolated from the roots. 2.1.3 Leaves Garrett C Smith et al (1996) extracted a series of vitamin A precursors from the leaves of A.digitata. Alpha carotene was found at 1.01mg/100g, beta-carotene was found at 5.92mg/100g, and cryptoxanthin was found at 0.81mg/100g of leaves. 2.1.4 Bark A review by Y N Shukla et al (2001) reported that friedelin, lupeol, baurenol, and betulinic acid had all been isolated from the bark of A. digitata. Tuani et al (1997) found several classes of compounds including flavonoids, glycosides, and tannins, but did not mention specific compounds. 2.1.5 Fruit Al-Qawari et al (2003), states that the triterpenoids beta-sitosterol, beta-amyrin palmitate, alpha-amyrin palmitate, and ursolic acids have been found in the fruit.